Search for Regulatory References | Drugs
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| Name | Topics |
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Pharmaceutical Quality and Manufacturing |
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Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval |
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Ethical Considerations for Clinical Investigations Involving Children -Guidance Snapshot |
Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval |
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Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval |
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Patient-Focused Drug Development Clinical Outcome Assessments |
Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval |
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Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval |
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Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval |
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Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval |
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Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval |
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Benefit-Risk Assessment for New Drug and Biologic Products Snapshot |
Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval |
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Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval |
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Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval |
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Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval |
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Regulations, Laws, Guidances; Meetings, Engaging with FDA |
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Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval |
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Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval |
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Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval |
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Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval |
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Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval |
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Patient-Focused Drug Development Clinical Outcome Assessments |
Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval |
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Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval |
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Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval |
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Population Pharmacokinetics Guidance Recap Podcast Transcript |
Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval |
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Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval |
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Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval |
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In Vitro Drug Interaction Studies Guidance Recap Podcast Transcript |
Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval |
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Clinical Drug Interaction Studies Guidance Recap Podcast Transcript |
Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval |
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Complex Innovative Trial Designs Guidance Recap Podcast Transcript |
Regulations, Laws, Guidances; Meetings, Engaging with FDA |
| Complex Generics News | Generic Drugs, Abbreviated New Drug Applications |
| Emerging Technology Program | Pharmaceutical Quality and Manufacturing |
| Oncology Regulatory Expertise and Early Guidance (OREEG) |
Clinical Trials, Drug Development and Approval, Investigational New Drug Development Application (IND), Meetings, Engaging with FDA |
| OTC Monographs@FDA | Over-the-Counter Drug Review |
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Over-the-Counter (OTC) Drug Review | OTC Monograph Reform in the CARES Act |
Over-the-Counter Drug Review |
| Phonetic and Orthographic Computer Analysis (POCA) Program | Drug Safety; Clinical Trials, Drug Development and Approval |
| About CDER Small Business and Industry Assistance | About FDA and CDER |
| About FDA | About FDA and CDER |
| CDER Exclusivity Board | About FDA and CDER |
| CDER Ombudsman | About FDA and CDER |
| Doing Business With FDA | About FDA and CDER |
| Jobs at FDA | About FDA and CDER |
| Biosimilar Development, Review, and Approval | Biologics, Biosimilars, Biologics License Application (BLA) |
| Biosimilar Product Information (FDA-Approved List of Biological Products) | Biologics, Biosimilars, Biologics License Application (BLA) |
| Biosimilars | Biologics, Biosimilars, Biologics License Application (BLA) |
| Biosimilars Action Plan | Biologics, Biosimilars, Biologics License Application (BLA) |
| Bisoimilar Industry Information and Guidance | Biologics, Biosimilars, Biologics License Application (BLA) |
| "Deemed to be a License” Provision of the BPCI Act | Biologics, Biosimilars, Biologics License Application (BLA) |
| Frequently Asked Questions About Therapeutic Biological Products | Biologics, Biosimilars, Biologics License Application (BLA) |
| Therapeutic Biologic Applications (BLA) Approval Information | Biologics, Biosimilars, Biologics License Application (BLA) |
| Transfer of Therapeutic Products to CDER | Biologics, Biosimilars, Biologics License Application (BLA) |
| Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations | Biologics, Biosimilars, Biologics License Application (BLA); Databases |
| Biosimilar User Fee Amendments (BsUFA) | Biologics, Biosimilars, Biologics License Application (BLA); User Fees |
| Biomarker Qualification Program | Clinical Trials, Drug Development and Approval |
| Combination Products | Clinical Trials, Drug Development and Approval |
| Clinical Trials and Human Subject Protection | Clinical Trials, Drug Development and Approval |
| Development & Approval Process | Clinical Trials, Drug Development and Approval |
| Drug Development and Drug Interactions: Table of Substrates, Inhibitors and Inducers | Clinical Trials, Drug Development and Approval |
| Drug Development Process | Clinical Trials, Drug Development and Approval |
| The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective | Clinical Trials, Drug Development and Approval |
| Economic Assistance and Incentives for Drug Development | Clinical Trials, Drug Development and Approval |
| Coronavirus (COVID-19) | Clinical Trials, Drug Development and Approval |
| COVID MyStudies Application (App) | Clinical Trials, Drug Development and Approval |
| Frequently Asked Questions on Patents and Exclusivity | Clinical Trials, Drug Development and Approval |
| Real-World Evidence | Clinical Trials, Drug Development and Approval |
| Compliance Actions and Activities | Compliance, Inspections, Enforcement |
| Inspections, Compliance, Enforcement, and Criminal Investigations | Compliance, Inspections, Enforcement |
| Unapproved Drugs | Compliance, Inspections, Enforcement |
| Warning Letters and Notice of Violation Letters to Pharmaceutical Companies | Compliance, Inspections, Enforcement |
| Compounding and the FDA: Questions and Answers | Compounding |
| Compounding Risk Alerts | Compounding |
| Compounding: Inspections, Recalls, and other Actions | Compounding |
| Human Drug Compounding | Compounding |
| Acronyms and Abbreviations Search | Databases |
| Drug Approvals and Databases | Databases |
| Drugs@FDA | Databases |
| FDALabel | Databases |
| Inactive Ingredient Database | Databases |
| National Drug Code Directory | Databases |
| Drug Shortages | Databases |
| Search List of Extended Use Dates to Assist with Drug Shortages | Databases |
| Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) | Databases; Generic Drugs, Abbreviated New Drug Application (ANDA) |
| Drug Master File webpage | Drug Master Files |
| Drug Master Files: Guidelines | Drug Master Files |
| Type II DMFs for Active Pharmaceutical Ingredients | Drug Master Files |
| Types of Drug Master Files (DMFs) | Drug Master Files |
| Drug Recalls | Drug Safety, Recalls |
| Drug Safety Communications | Drug Safety, Recalls |
| FDA Adverse Event Reporting System (FAERS) Public Dashboard | Drug Safety, Recalls |
| Medwatch | Drug Safety, Recalls |
| Preventable Adverse Drug Reactions: A Focus on Drug Interactions | Drug Safety, Recalls |
| Risk Evaluation and Mitigation Strategies (REMS) | Drug Safety, Recalls |
| Drug Safety Labeling Changes | Drug Safety, Recalls; Labeling |
| FDA Adverse Event Reporting System (FAERS) Electronic Submissions | Drug Safety, Recalls; Submissions, Forms, Contacts |
| Medwatch Reporting for Industry | Drug Safety, Recalls; Submissions, Forms, Contacts |
| Drug Safety and Availability | Drug Safety; Databases |
| Drug Supply Chain Integrity | Drug Supply Chain |
| Drug Supply Chain Security Act | Drug Supply Chain |
| Verify Wholesale Drug Distributor Licenses | Drug Supply Chain |
| Abbreviated New Drug Application (ANDA) | Generic Drugs, Abbreviated New Drug Application (ANDA) |
| Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry | Generic Drugs, Abbreviated New Drug Application (ANDA) |
| Dissolution Methods Database | Generic Drugs, Abbreviated New Drug Application (ANDA) |
| First Generic Drug Approvals | Generic Drugs, Abbreviated New Drug Application (ANDA) |
| Generic Drug Research-Related Guidances and Reports | Generic Drugs, Abbreviated New Drug Application (ANDA) |
| Generic Drugs: Information for Industry | Generic Drugs, Abbreviated New Drug Application (ANDA) |
| Guidance Documents for Generic Drugs (search Generics under topic) | Generic Drugs, Abbreviated New Drug Application (ANDA) |
| Guidance for Industry: ANDA Submission - Content and Format of ANDAs | Generic Drugs, Abbreviated New Drug Application (ANDA) |
| Orange Book Preface | Generic Drugs, Abbreviated New Drug Application (ANDA) |
| Patent Certifications and Suitability Petitions | Generic Drugs, Abbreviated New Drug Application (ANDA) |
| Product-Specific Guidances for Generic Drug Development | Generic Drugs, Abbreviated New Drug Application (ANDA) |
| Referencing Approved Drug Products in ANDA Submissions Guidance for Industry | Generic Drugs, Abbreviated New Drug Application (ANDA) |
| Self-Identification of Generic Drug Facilities, Sites and Organizations | Generic Drugs, Abbreviated New Drug Application (ANDA) |
| Pre-ANDA Program | Generic Drugs, Abbreviated New Drug Application (ANDA); Meetings, Engaging with FDA |
| FDA List of Authorized Generic Drugs | Generic Drugs, Abbreviated New Drug Application (ANDA); New Drug Review, New Drug Application (NDA) |
| ANDA Forms and Submissions Requirements | Generic Drugs, Abbreviated New Drug Application (ANDA); Submissions, Forms, Contacts |
| Controlled Correspondence | Generic Drugs, Abbreviated New Drug Application (ANDA); Submissions, Forms, Contacts |
| GDUFA web-based learning courses | Generic Drugs, Abbreviated New Drug Application (ANDA); User Fees |
| Generic Drug User Fee Amendments (GDUFA) | Generic Drugs, Abbreviated New Drug Application (ANDA); User Fees |
| Export certificates | Import/Export, Regulatory Affairs, International Programs |
| Import and Export of Human Drugs and Biologics | Import/Export, Regulatory Affairs, International Programs |
| Information for Exporters | Import/Export, Regulatory Affairs, International Programs |
| Office of Global Policy and Strategy | Import/Export, Regulatory Affairs, International Programs |
| Office of Regulatory Affairs (ORA) Directory | Import/Export, Regulatory Affairs, International Programs; Submissions, Forms, Contacts |
| Expanded Access: Information for Industry | Investigational New Drug Application (IND) |
| Expedited Programs | Investigational New Drug Application (IND) |
| Exploratory INDs | Investigational New Drug Application (IND) |
| IND Exemptions | Investigational New Drug Application (IND) |
| Investigational New Drug (IND) Application | Investigational New Drug Application (IND) |
| Investigator-Initiated INDs and IND submission procedures | Investigational New Drug Application (IND) |
| Pregnancy and Lactation Labeling (Drugs) Final Rule | Labeling |
| FDA’s Labeling Resources for Human Prescription Drugs | Labeling |
| Table of Pharmacogenomic Biomarkers in Drug Labeling | Labeling |
| Medication Guides | Labeling; Databases |
| Advisory Committees (human drugs) | Meetings, Engaging with FDA |
| Best Practices for Communication Between IND Sponsors and FDA During Drug Development | Meetings, Engaging with FDA |
| Engaging with FDA during New Drug Development CDERLearn Course | Meetings, Engaging with FDA |
| News & Events for Human Drugs | Meetings, Engaging with FDA; About FDA and CDER |
| Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry | Meetings, Engaging with FDA; Generic Drugs, Abbreviated New Drug Application (ANDA) |
| Pre-IND Meeting FAQs | Meetings, Engaging with FDA; Investigational New Drug Application (IND) |
| Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry | Meetings, Engaging with FDA; Biologics, Biosimilars, Biologics License Application (BLA) |
| Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products | Meetings, Engaging with FDA; Investigational New Drug Application (IND); New Drug Review, New Drug Application (NDA) |
| New Drug Application (NDA) Resources | New Drug Review, New Drug Application (NDA) |
| Pre-IND Consultation Program | New Drug Review, New Drug Application (NDA) |
| Requesting a Pre-Assigned Application number | New Drug Review, New Drug Application (NDA) |
| Coronavirus Treatment Acceleration Program (CTAP) | New Drug Review, New Drug Application (NDA); Clinical Trials, Drug Development and Approval |
| Applications Covered by Section 505(b)2) Guidance for Industry | New Drug Review, New Drug Application (NDA); Investigational New Drug Application (IND) |
| Prescription Drug User Fee Amendments (PDUFA) | New Drug Review, New Drug Application (NDA); User Fees |
| User Fee Waivers, Reduction, and Refunds for Drug and Biological Products - Guidance for Industry | New Drug Review, New Drug Application (NDA); User Fees |
| Development and Regulation of OTC (Nonprescription) Drugs | Over-the-Counter Drug Review |
| Drug applications for OTC drugs | Over-the-Counter Drug Review |
| OTC Monographs and Rulemaking | Over-the-Counter Drug Review |
| Over-the-Counter (OTC) Drug Monograph Process | Over-the-Counter Drug Review |
| Over-the-Counter Monograph User Fee Program (OMUFA) | Over-the-Counter Drug Review; User Fees |
| BlackBerry QNX Cybersecurity Vulnerabilities May Affect Drug Manufacturing Equipment | Pharmaceutical Quality and Manufacturing |
| Current Good Manufacturing Practice (CGMP) Regulations | Pharmaceutical Quality and Manufacturing |
| Developing and Manufacturing Drugs Including Biologics | Pharmaceutical Quality and Manufacturing |
| Drug Quality Sampling and Testing Programs | Pharmaceutical Quality and Manufacturing |
| Expiration Dates - Questions and Answers | Pharmaceutical Quality and Manufacturing |
| Facts About CGMPs | Pharmaceutical Quality and Manufacturing |
| Pharmaceutical Quality Resources | Pharmaceutical Quality and Manufacturing |
| Quality Metrics for Drug Manufacturing | Pharmaceutical Quality and Manufacturing |
| Questions and Answers on CGMPs | Pharmaceutical Quality and Manufacturing |
| Questions and Answers on Current Good Manufacturing Practices—Control of Components and Drug Product Containers and Closures | Pharmaceutical Quality and Manufacturing |
| Questions and Answers on Current Good Manufacturing Practices—Production and Process Controls | Pharmaceutical Quality and Manufacturing |
| Report a Product Quality Issue | Pharmaceutical Quality and Manufacturing |
| Current Good Manufacturing Practice (CGMP) Regulations | Pharmaceutical Quality and Manufacturing; Regulations, Laws, Guidances |
| Office of Prescription Drug Promotion (OPDP) | Post-Marketing Activities and Promotion |
| Truthful Prescription Drug Advertising and Promotion (Bad Ad Program) | Post-Marketing Activities and Promotion |
| Postmarket Drug Safety Information for Patients and Providers | Post-Marketing Activities and Promotion; Drug Safety |
| Postmarketing Surveillance Programs | Post-Marketing Activities and Promotion; Drug Safety |
| Developing Products for Rare Diseases and Conditions | Rare Diseases and Orphan Drugs |
| Frequently Asked Questions (FAQ) About Designating an Orphan Product | Rare Diseases and Orphan Drugs |
| Search Orphan Drug Designations and Approvals | Rare Diseases and Orphan Drugs |
| CDER Direct: Electronic Submissions Portal | Registration and Listing |
| Electronic Drug Registration and Listing Instructions | Registration and Listing |
| Drug Establishments Current Registration Site (DECRS Database) | Registration and Listing; Databases |
| Registered Outsourcing Facilities (Compounding) | Registration and Listing; Databases |
| Code of Federal Regulations, Title 21 | Regulations, Laws, Guidances |
| Federal Food Drug & Cosmetic Act | Regulations, Laws, Guidances |
| Laws, Regulations and Guidances | Regulations, Laws, Guidances |
| Search for FDA Guidance Documents | Regulations, Laws, Guidances |
| CDER Reports & Budget | Reports |
| Division of Applied Regulatory Science Annual Reports | Reports |
| Drug and Biologic Approval and IND Activity Reports | Reports |
| Fast Track Approvals | Reports |
| GDUFA Science and Research Reports | Reports |
| IND Application Reporting: Safety Reports | Reports |
| NDA and BLA Approvals | Reports |
| NDA and BLA Calendar Year Approvals | Reports |
| Office of Clinical Pharmacology Annual Reports | Reports |
| Office of Generic Drugs Annual Reports | Reports |
| Office of New Drugs Annual Reports | Reports |
| Office of Pharmaceutical Quality Annual Reports | Reports |
| CDER Data Standards Program | Submissions, Forms, Contacts |
| CDER Direct NextGen Collaboration Portal | Submissions, Forms, Contacts |
| CDER Direct NextGen Collaboration Portal FAQs | Submissions, Forms, Contacts |
| Electronic Regulatory Submission and Review | Submissions, Forms, Contacts |
| FDA Forms | Submissions, Forms, Contacts |
| Forms and Submission Requirements | Submissions, Forms, Contacts |
| Office of New Drugs Contacts | Submissions, Forms, Contacts |
| Reorganization of the Office of New Drugs | Submissions, Forms, Contacts |
| Addresses for regulatory submissions | Submissions, Forms, Contacts; Investigational New Drug Application (IND); New Drug Review, New Drug Application (NDA); Generic Drugs, Abbreviated New Drug Application (ANDA) |
| Electronic Common Technical Document (eCTD) | Submissions, Forms, Contacts; Investigational New Drug Application (IND); New Drug Review, New Drug Application (NDA); Generic Drugs, Abbreviated New Drug Application (ANDA) |
| FDA IND, NDA, ANDA, or Drug Master File Binders | Submissions, Forms, Contacts; Investigational New Drug Application (IND); New Drug Review, New Drug Application (NDA); Generic Drugs, Abbreviated New Drug Application (ANDA); Drug Master Files |
| CDER SBIA Learn: Respository of Training Resources and Recordings | Training Resources |
| CDERLearn Training and Education | Training Resources |
| Stay Informed with FDA Interactive Media | Training Resources |
| Video and Transcript: FDA/CDER's Small Business and Industry Assistance (SBIA) | Training Resources |
| FDA User Fee Programs | User Fees |